8 SynCardia Certified Centers & Surgeons
Honored for Use of Total Artificial Heart at ISHLT
Awards Include Pediatric Pioneers, Best Launches, Fastest Certification and Proctoring Excellence
TUCSON, Ariz. – May 3, 2012 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, honored eight SynCardia Certified Centers and surgeons for their use of the SynCardia temporary Total Artificial Heart and the Freedom® portable driver during the annual meeting of the International Society for Heart & Lung Transplantation (ISHLT) held April 18-21 in Prague, Czech Republic.
Pediatric Pioneer Award
• Dr. David L.S. Morales, Texas Children's Hospital
• Dr. William Gaynor, Children's Hospital of Philadelphia (CHOP)
Achievement: These surgeons exhibited leadership in use of the SynCardia Total Artificial Heart for pediatric patients suffering from congenital heart failure
Texas Children's became the first pediatric hospital in the world to implant the Total Artificial Heart in May 2011. The patient, 17-year-old Jordan Merecka, had been born with a "reversed" heart (dextrocardia) and his heart vessels backwards (corrected transposition of the great arteries). He went on to become the first pediatric Total Artificial Heart patient to be discharged from the hospital using the Freedom portable driver and received his heart transplant on Oct. 20, 2011.
CHOP became the first hospital to implant the Total Artificial Heart into a pediatric patient suffering from a failed Fontan procedure in January 2012. The teenager was bridged to transplant in March 2012.
Best Launch Award
• U.S. – Texas Heart Institute
• U.S. – University of Washington (UW) Medical Center
• International – EJK Duisburg (Germany)
Achievement: These hospitals were recognized for their rapid use of the SynCardia Total Artificial Heart and Freedom portable driver. Texas Heart Institute performed its first four implants in just 12 days, UW Medical Center performed its first four implants in just 35 days, and EJK Duisburg performed 3 implants in just 20 days.
Fastest Certification Award
• Dr. Charles Hoopes & Team, University of Kentucky (UK) Medical Center
Achievement: UK Medical Center completed SynCardia's four-phase Certification Program in record time to save the life of 20-year-old Zack Poe, who was discharged home using the Freedom portable driver just 25 days after the hospital completed its first phase of certification.
Proctoring Impact Award
• U.S. - Dr. Francisco Arabia
• International - Dr. Latif Arusoglu
Achievement: These world-class Total Artificial Heart surgeons work tirelessly to promote good patient outcomes with the SynCardia Total Artificial Heart by proctoring first patient implants at transplant hospitals around the world.
During ISHLT, several of the surgeons above also participated in SynCardia's Clinical Investigator's Meeting for the Freedom® portable driver, the world's first wearable power supply for the Total Artificial Heart. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, firstname.lastname@example.org, (520) 547-7463